Chronic Presence of Epstein Barr Virus in Sulcular and Junctional Epithelial Tissue From Gingiva is Associated With Severe Periodontitis

NCT01246648 | Completed

• 1 other identifier: 10-PP-13
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease. The main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.

Conditions

Parodontitis Aggressive; Parodontitis Chronic

Outcome Measures

Primary Outcomes (1)

• Presence/absence of EBV in the epithelial cells of periodontal pockets (by Immunofluorescence and in situ Hybridization

  at time = 0 (baseline)

Secondary Outcomes (2)

• Presence/ absence of latency and/or lytic proteins (by immunofluorescence and in situ hybridization

  at time = 0 (baseline)

• - Epithelial tissue infected (by Immunofluorescence and In situ Hybridization) : detection of oral gingival epithelium, sulcular epithelium, junctional epithelium.

  at time = 0 (baseline)

Study Arms (3)

chronic periodontitis

ACTIVE COMPARATOR

Procedure: Biopsy

agressive periodontitis

ACTIVE COMPARATOR

Procedure: biopsy

healthy patients

ACTIVE COMPARATOR

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

dental extraction and gingival epithelial biopsy

chronic periodontitis

Eligibility Criteria

• Age: 12 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men exclusively
• years minimum
• patients affected by chronic periodontitis
• patients affected by aggressive periodontitis
• healthy patients (orthodontics extraction)
• Subject who have read and understood the information note relative under investigation and who have signed the informed consent
• Subject whose legal representative signed the parental consent (if minor patient)

You may not qualify if:

• Patient with contre-indication to dental extraction
• Patient witn serious blood disease
• Patient who exhibits systemic condition incompatible with the realization of the study
• Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
• Patient who presents za buccal carcinoma treated with radiotherapy
• Patient who have received during the past 6 months: anti-inflammatory drugs, anti-cancerous or immunosuppressive chemiotherapy
• Patient who presents a linguistic or psychic incapacity to understand information
• Female patient

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice, Hôpital Saint Roch

Nice, 06000, France

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• VINCENT Severine, PH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 23, 2010
• Study Start: January 17, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

FR (1)